CN101711138B - Novel artificial blood vessel - Google Patents
Novel artificial blood vessel Download PDFInfo
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- CN101711138B CN101711138B CN2008800160056A CN200880016005A CN101711138B CN 101711138 B CN101711138 B CN 101711138B CN 2008800160056 A CN2008800160056 A CN 2008800160056A CN 200880016005 A CN200880016005 A CN 200880016005A CN 101711138 B CN101711138 B CN 101711138B
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/064—Blood vessels with special features to facilitate anastomotic coupling
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/065—Y-shaped blood vessels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/068—Modifying the blood flow model, e.g. by diffuser or deflector
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
Abstract
The invention relates to a vascular prosthesis comprising a fork-shaped tube, comprising: an inflow conduit having an inflow end (6); a distal main outflow branch having a distal main outflow end (8); and a secondary proximal outflow branch having a secondary proximal outflow end (7). The two outflow ends are directed in different directions and the two outflow branches have different cross-sectional areas in the vicinity of the bifurcation (9). Further, the secondary proximal outflow branch is more curved than the primary distal outflow branch, the secondary proximal outflow branch having a smaller cross-sectional area adjacent the bifurcation than the primary distal outflow branch. Thus, the energy loss at the flow bifurcation is adapted to the bypass condition to equalize the shear stress level, thereby avoiding areas with low shear stress and reducing the likelihood of turbulence, thereby reducing the risk of stenosis of the graft vessel.
Description
Technical field
The present invention relates to artificial blood vessel, and relate more specifically to be used for the treatment of the fork-shaped artificial blood vessel that limits geometry that has of angiemphraxis disease.
Background technology
Human mortality rate is main relevant with arteriosclerosis.Arteriosclerosis is narrow treats through chamber vascular plasty (balloon expandable) or by-pass operation by percutaneous.Now, only just implement the revascularization that 1,500,000 examples adopt this technology every year in the U.S..About 40% patient is because restenosis or graft stenosis and again experienced blood vessel narrow down in 1 year, this restenosis or graft stenosis and then can cause organ ischemia recurrence are so that myocardial infarction forms, the incidence rate of shank amputation and apoplexy enlarges markedly.Only in the U.S., the annual expense that is used for shank implantable graft angiostenosis is estimated to reach 100,000,000 dollar.
Graft stenosis is because due to the neointimal hyperplasia (IH).IH is characterised in that, the migration of smooth muscle cell and propagation and apposition subsequently.IH can be considered to the overreaction of scar tissue.Recent evidence shows that IH develops mainly owing to the hematodinamics physical force.The pushing force (shear stress) that is applied by blood reduces, make in the intrinsic blood vessel transplantation blood vessel of body (Morinaga1987), in the repairing transplant blood vessel (Geary 1994) and the development of the IH in the impaired tremulous pulse of sacculus (Bassiony1998) accelerate.Blood flow increases (shear stress increase) and causes that formed IH disappears in grafting vessel (Mattsson 1997).The high transmutability of shear stress level also may make the risk of IH increase (Nanjo 2006).Another important hemodynamic factors is turbulent flow.Turbulent flow increases the amount rising (Fillinger 1989) that makes IH.Therefore, the improvement of the Clinical Processing of graft stenosis depended on medical science and physical knowledge (Sarkar 2006).
Now, the narrow bypass for the treatment of is implanted to tremulous pulse (Fig. 2) with end to the side formula.This is at " toe " and " root " of connecting portion, particularly at the lower shear stress (Ojha1993 of distal anastomosis section generation; Ojha 1994) (Fig. 3).The development of IH is because the further aggravation with the fact of the common location, zone with mild method of anastomotic part seam.The damage and the shear stress level that cause owing to seam in the blood vessel wall cause cell with the growth of different mechanisms jointly, and produce subsequently IH.Mild method also will appear at the place, tributary in the receptor tremulous pulse.And the end of standard connects to side and causes local increase (Fig. 4) of radius.When radius increased, shear stress level reduced.Thereby operation process causes mild method and causes local I H.
The bypass graft blood vessel of standard also forms turbulent flow at toe and the heel of connecting portion.Turbulent flow is known IH priming factors (Fillinger 1989).
End in by-pass operation faces other serious problems to the side connection.Wherein going out section and secondary flow by the downstream main flow goes out section and forms branched portion.Because tremulous pulse has its given diameter, thereby these two outflow sections have identical sectional area, although the requirement of blood flow is different.The separation angle that has 180 degree between these " branch roads ".These two limitations are parts of the restrictive condition of institute of the present invention concerned issue.
Therefore, improved grafting vessel should be able to provide and have low as far as possible variable shearing force and as far as possible little turbulent flow.This will reduce the probability that causes IH and the opening of improving grafting vessel.The further target of improved bypass should be: make that driving pressure is poor between required grafting vessel end minimizes.So that exist when narrow when the bypass distally, blood has stronger mobile ability through conduit like this.Blood flow is separated it is located away from anatomically because the damage due to the operation seam.Thus, at the connecting portion for the key of receptor tremulous pulse bypass, IH priming factors, hemodynamic factors and damage will can not exist simultaneously.
WO 2006/100659 has described the artificial blood vessel of fork-shaped tube shaped.But, this open source literature does not provide the description to the required geometric properties of following artificial blood vessel: have enough low variable sufficiently high shear stress and enough little turbulent flow with the probability that reduces initiation IH and the artificial blood vessel that improves the grafting vessel opening.
Summary of the invention
Therefore, the object of the invention is to, a kind of artificial blood vessel that alleviates above-mentioned prior art problem is provided.This purpose realizes by the artificial blood vessel according to appended claims.
According to the first scheme of the present invention, a kind of artificial blood vessel that comprises the fork-shaped pipeline is provided, comprising: have the flow ipe that flows into end; Distally main flow out branch with distally master's outflow end; With the nearside secondary flow out branch with the secondary outflow end of nearside; Described two outflow ends guide along different directions; And described two outflow branch roads have different cross-sectional in the adjacent place of branched portion; Wherein, described nearside secondary flow out branch is more crooked than described distally main flow out branch, and described nearside secondary flow out branch has in the adjacent place of described branched portion than the less sectional area of described distally main flow out branch.
In the application's context, the distally is used for expression away from the direction of heart, and nearside represents the direction towards heart.
By new artificial blood vessel, can easily realize the iptimum relationship between the radius and between the angle, as described in more detail hereinafter.New artificial blood vessel significantly reduces the energy consumption of branched portion, this equilibrium shear stress level, avoid thus having the zone of mild method and reduce the probability of turbulent flow.Because mild method and turbulent flow are the known hemodynamic factors that causes graft stenosis, therefore, by new artificial blood vessel the risk of this combined influence are significantly reduced.
In the adjacent place of described branched portion, the ratio of the radius r of described nearside secondary flow out branch and the radius ρ of described flow ipe is preferably in 0.4 to 0.69 scope, and most preferably in 0.45 to 0.65 scope.In the adjacent place of described branched portion, the radius R of described distally main flow out branch and the ratio of the radius ρ of described flow ipe are preferably in 0.7 to 1.0 scope, and most preferably in 0.75 to 0.95 scope.
The outflow angle [alpha] that enters described distally main flow out branch from described flow ipe is preferably in the scope of 0 to 40 degree, and more preferably in the scopes of 5 to 30 degree, and most preferably in the scopes of 8 to 25 degree.Further, the outflow angle beta that enters described nearside secondary flow out branch from described flow ipe is preferably in the scopes of 30 to 90 degree, and more preferably in the scopes of 40 to 70 degree, and most preferably in the scopes of 45 to 65 degree.
Further, preferably, described secondary flow goes out the curved radius of curvature r in middle part of section
cAll greater than the twice of the radius ρ of described inflow section, and preferably, described secondary flow goes out the curved radius of curvature r in middle part of section at all sites
cHas the minima place less than six times of the radius ρ of described inflow section at it.
Preferably, two outflow ends all are suitable for being connected to the tremulous pulse of radius in 0.5 to 10mm scope.Further, one or two in the described outflow end can be tapered to be suitable for the receptor tremulous pulse.
Preferably, described nearside secondary flow out branch has the cumulative sectional area from described branched portion to described outflow end.Thus, provide seamlessly transitting from the long-pending larger sectional area to outflow end of the small cross sections of branched portion.
Preferably, enter the outflow angle beta of the secondary outflow end of described nearside greater than the outflow angle [alpha] that enters described distally master's outflow end from described flow ipe from described flow ipe.
According to another aspect of the present invention, provide a kind of method of using the aforementioned type artificial blood vessel to carry out surgical procedures, described method comprises with any in sequence following steps:
A) cutting receptor tremulous pulse and isolate the end of exposing by cutting;
B) distally master's outflow end of described artificial blood vessel is sewn onto expose the downstream of tremulous pulse;
C) the secondary outflow end of the nearside of described artificial blood vessel is sewn onto expose the upstream extremity of tremulous pulse; With
D) the inflow end with described artificial blood vessel is attached to blood vessel, so that blood is fed to described receptor tremulous pulse by described artificial blood vessel.
Description of drawings
By only being used for illustrative description referring to accompanying drawing to what some embodiments of the invention were carried out, the present invention will more clearly be understood, wherein:
Fig. 1The illustration figure of atherosclerotic tremulous pulse.
Fig. 2Be the illustration figure that demonstrates according to the standard bypass graft blood vessel of prior art, upstream and downstream is attached to be " end is to side ".
Fig. 3The illustration figure that in according to the vascular anastomosis art of prior art, limits " heel " 1 and " toe " 2.
Fig. 4That this illustration figure demonstrates receptor tremulous pulse 3 and grafting vessel 4, notices at attached position 5 because adding material (grafting vessel) has the diameter of expansion according to the illustration figure of " end is to side " connecting portion of the standard of prior art.
Fig. 5The schematic illustration figure with the artificial blood vessel of the present invention of Lycoperdon polymorphum Vitt demonstration.
Fig. 6The computer simulation result with the blood flow that passes through the standard grafting vessel of comparing by the blood flow of artificial blood vessel of the present invention.Map-area A: the blood flow in the standard bypass graft blood vessel, map-area B: the blood flow in the artificial blood vessel of the present invention.
Fig. 7Be and the computer simulation result of the shear stress level of grafting vessel by standard and new artificial blood vessel, color is darker, and then shear stress is lower, and same pressure difference is used for two kinds of grafting vessels.Map-area A: the shear stress in the standard bypass graft blood vessel, map-area B: the shear stress in the artificial blood vessel of the present invention.
Fig. 8Each radius Relations Among at the fork position in artificial blood vessel of the present invention and the illustration figure of each angle Relations Among.
Fig. 9That secondary flow goes out the curved radius of curvature r in middle part of section
cAnd the illustration figure of the relation between the radius ρ of inflow section.
The specific embodiment
The invention provides a kind of artificial blood vessel that comprises the fork-shaped pipeline, it comprises: have the flow ipe that flows into end; Distally main flow out branch with distally master's outflow end; With the nearside secondary flow out branch with the secondary outflow end of nearside; Wherein, described two outflow ends guide along different directions; And described two outflow branch roads have different cross-sectional at first; Wherein, described nearside secondary flow out branch is more crooked than described distally main flow out branch.
Fig. 5 example illustrates the example of artificial blood vessel of the present invention.Flow into end and be attached to the receptor tremulous pulse by common " end is to side " connecting portion 6, and the secondary outflow end 7 of distally master's outflow end 8 and nearside is connected to the receptor tremulous pulse in " end-to-end " mode.In grafting vessel, comprise tributary branched portion 9.Two outflow branch roads have different cross-sectional at first, that is, close vicinity after artificial blood vessel is divided into the position of two branch roads, that is, in its direct junction with the fork position, two outflow branch roads have different cross-sectional.
The ratio of the ratio of the radius (r among Fig. 8) that the nearside secondary flow goes out section and the radius (ρ among Fig. 8) of inflow section and the radius (R among Fig. 8) that the distally main flow goes out section and the radius of inflow section is the favorable characteristics of artificial blood vessel of the present invention.Fig. 8 example is illustrated in according between each radius of fork position in the artificial blood vessel of the embodiment of the invention and the relation between each angle.The inflow section of tubular blood vessel is two branch roads, and the distally main flow with radius R goes out section and goes out section with the nearside secondary flow with radius r.Close vicinity after artificial blood vessel is divided into the position of two branch roads namely, in its direct junction with the fork position, is measured radius R and the nearside secondary flow that the distally main flow goes out section and is gone out the radius r of section.
Different radii and sectional area at artificial blood vessel different parts place are measured based on the artificial blood vessel inboard.
Inflow section has radius ρ.Take measurement of an angle at the fork position, the angle that the distally main flow goes out section is given as α, and the angle that secondary flow goes out section is given as β.Fork position 12 is restricted to: the curved position that is divided into two outflow sections, the middle part of upstream tubular blood vessel.What notice is that the angle between these outflow sections is alpha+beta.
The relation of radius is preferably given by following ratio among Fig. 8:
●0.7<R/ρ<1
●0.4<r/ρ<0.69
Alternately,
●R/ρ=0.85±0.15
●r/ρ=0.55±0.15
Angle is given as take degree as unit: α=20 ° ± 20 °, β=60 ° ± 30 °.
The radius R that the radius r that the nearside secondary flow goes out section and ratio and the distally main flow of the radius ρ of inflow section go out section and the ratio of the radius ρ of inflow section are the favorable characteristics of artificial blood vessel of the present invention.
Therefore, in one embodiment of the invention, artificial blood vessel is characterised in that, the radius r that the nearside secondary flow goes out section and the ratio of the radius ρ of inflow section are in 0.4 to 0.69 scope.
In another embodiment of the present invention, artificial blood vessel is further characterized in that, the radius R that the distally main flow goes out section and the ratio of the radius ρ of inflow section are in 0.7 to 1.0 scope.
The concept of " radius " is used in broader terms, thereby the radius of noncircular cross section is restricted to the radius with the long-pending disk of same cross-sectional.
In a preferred embodiment of the invention, artificial blood vessel is characterised in that, the radius r that the nearside secondary flow goes out section and the ratio of the radius ρ of inflow section are in 0.45 to 0.65 scope, more particularly in 0.5 to 0.62 scope, and/or, the radius R that the distally main flow goes out section and the ratio of the radius ρ of inflow section are in 0.75 to 0.95 scope, more particularly in 0.8 to 0.95 scope.
Therefore, in artificial blood vessel according to the present invention, the sectional area that the distally main flow goes out section goes out the sectional area of section at initial (that is, in the adjacent place of branched portion) greater than the nearside secondary flow, thereby the downstream main flow that goes out in the section for the distally main flow provides priority.
According to this embodiment of the present invention, preferably, the sectional area that the distally main flow that artificial blood vessel has goes out section and nearside secondary flow go out the ratio of sectional area of section greater than 1, and are preferably more than 2.
The distally main flow goes out angle (α among Fig. 8) and the nearside secondary flow goes out angle (β among Fig. 8), is the further favorable characteristics of artificial blood vessel of the present invention.
The distally main flow goes out angle [alpha] and is measured at the curved and distally main flow in middle part at fork position flow ipe 13a and goes out the middle part of the pipeline 13b angle between curved.The nearside secondary flow goes out angle beta and is measured at the curved and nearside secondary flow in middle part at fork position flow ipe 13a and goes out the middle part of the pipeline 13c angle between curved.The fork position is restricted to the curved position that is divided into two branch roads, middle part of upstream tubular blood vessel.
In another embodiment of the present invention, artificial blood vessel is characterised in that the distally main flow goes out angle [alpha] in the scope of 0 to 40 degree, for example in the scope of 5 to 30 degree, or more particularly in the scope of 8 to 25 degree; The nearside secondary flow goes out angle beta in the scope of 30 to 90 degree, for example in the scope of 40 to 70 degree, or more particularly in the scope of 45 to 65 degree.
In a preferred embodiment, the distally main flow go out angle [alpha] be 10 the degree.In another preferred embodiment, the nearside secondary flow go out angle beta be 50 the degree.
In another embodiment of the present invention, artificial blood vessel is characterised in that the distally main flow goes out section and/or the nearside secondary flow goes out the curvature that section has restriction.
Fig. 9 example illustrates the curved radius of curvature r in middle part that secondary flow goes out section
cAnd the relation between the radius ρ of inflow section.To go out the middle part of section curved and along this curved coupling one tangent circle, can estimate that secondary flow goes out the radius of curvature at the middle part of section by following secondary flow.Be restricted to tangent radius of a circle at this position in the radius of curvature of specific part.Tangent circle with least radius can come across curved position with maximum curvature, middle part.The nearside secondary flow goes out the curved radius of curvature r in middle part of section
cIt is the further favorable characteristics of artificial blood vessel of the present invention.The nearside secondary flow goes out the curved radius of curvature r in middle part of section
cAlways greater than the twice of the radius ρ of inflow section.Therefore, the maximum that exists the nearside secondary flow to go out section allows curvature.Go out the curved radius of curvature r in middle part of section at secondary flow
cPosition with its minima, it is less than six times of the radius ρ of inflow section.Therefore, the minimum that exists the nearside secondary flow to go out section allows curvature.
In another embodiment of the present invention, artificial blood vessel is characterised in that the nearside secondary flow goes out the curved radius of curvature r in middle part of section
cAll greater than the twice of the radius ρ of inflow section, secondary flow goes out the curved radius of curvature r in middle part of section at all sites
cAt its position with minima less than six times of the radius ρ of inflow section.
In a preferred embodiment of the invention, artificial blood vessel is characterised in that the nearside secondary flow goes out the curved radius of curvature r in middle part of section
cWith the ratio of the radius ρ of inflow section at all sites all greater than 2, for example, greater than 3.
In a preferred embodiment of the invention, two or more features as limiting in the preamble according to artificial blood vessel of the present invention are combined.
Therefore, in a preferred embodiment, the invention provides a kind of artificial blood vessel that comprises the fork-shaped pipeline, it has inflow section, and the distally main flow goes out section, and the nearside secondary flow goes out section, it is characterized in that:
A) the nearside secondary flow radius r that goes out section and the ratio of the radius ρ of inflow section are in 0.4 to 0.69 scope, for example in 0.45 to 0.65 scope, or more particularly in 0.5 to 0.62 scope, the radius R that the distally main flow goes out section with/or the ratio of the radius ρ of inflow section in 0.7 to 1.0 scope, for example in 0.75 to 0.95 scope, or more particularly in 0.8 to 0.95 scope;
B) the distally main flow goes out angle [alpha] in the scope of 0 to 40 degree, for example in the scope of 5 to 30 degree, or more particularly in the scope of 8 to 25 degree;
C) the nearside secondary flow goes out angle beta in the scope of 30 to 90 degree, for example in the scope of 40 to 70 degree, or more particularly in the scope of 45 to 65 degree; And/or
D) the nearside secondary flow goes out the curved radius of curvature r in middle part of section
cAll greater than the twice of the radius ρ of inflow section, secondary flow goes out the curved radius of curvature r in middle part of section at all sites
cHas the minima place less than six times of the radius ρ of inflow section at it.
Two outflow ends of artificial blood vessel of the present invention all can be suitable for being connected to the tremulous pulse of radius in 0.5 to 10mm scope.Therefore, the radius ρ of the inflow section of artificial blood vessel of the present invention can be in 0.5 to 10mm scope.
The wall of artificial blood vessel can preferably have 0.01 to 3mm thickness.The thickness of the wall of artificial blood vessel can change according to the different piece of artificial blood vessel, with the maximum stability at permission branched portion place, and allows more easily to sew up at inflow end and outflow end.
Flowing into end and outflow end can be enhanced to allow fully effectively to keep to sew up.
Two outflow ends of artificial blood vessel of the present invention all can be suitable for coincideing end to end with the receptor tremulous pulse.
In one embodiment of the invention, one or two in the artificial blood vessel outflow end is that taper is to be fit to the receptor tremulous pulse.Described end can be inside or outside taper.Term " taper " increases gradually for the radius that limits outflow end or reduces.
Artificial blood vessel according to the present invention provides has low variable shearing force and low turbulent flow.This will reduce the probability that causes IH and the opening of improving grafting vessel.Further make poor the minimizing of driving pressure between required grafting vessel end according to artificial blood vessel of the present invention.Cause like this existing when narrow when the bypass distally, blood has stronger mobile ability through conduit.It is located away from anatomically in the separation of blood flow because operation puts on the damage that the eparterial seam of receptor causes.Thus, at the connecting portion for the key of receptor tremulous pulse bypass, IH priming factors, hemodynamic factors and damage will can not exist simultaneously.
The present invention further provides a kind of use and carry out the method for surgical procedures according to artificial blood vessel of the present invention, described method comprises with any in sequence following steps:
A) cutting receptor tremulous pulse and isolate the end of exposing by cutting;
B) distally master's outflow end of described artificial blood vessel is sewn onto expose the downstream of tremulous pulse;
C) the secondary outflow end of the nearside of described artificial blood vessel is sewn onto expose the upstream extremity of tremulous pulse; With
D) the inflow end with described artificial blood vessel is attached to blood vessel, so that blood is fed to described receptor tremulous pulse by described artificial blood vessel.
The design of preferred embodiment
In decision design, we are local Mohs law (Murray ' s law) (the Murray 1926a that adopts at the fork position, Murray 1926b, Zamir 1978, with people 1986 such as Woldenberg), wherein be limited between the radius that the blood flow branched portion produces the energy consumption minimum and the iptimum relationship of (seeing Fig. 8) between the angle, and the zone (Fig. 7) of balanced shear stress level to avoid having mild method, and reduce the probability of turbulent flow.But, bypass situation is different from the ideal flow situation that limits by the Mohs law.Bypass has outflow section in opposite direction.It is long-pending that the receptor tremulous pulse has same cross-sectional, goes out section even the priority of blood flow should be given the distally main flow.This decision design is the balance between optimum shunting and the controlled curvature (Fig. 9) that goes out section with the taper secondary flow effectively reboot outflow section, thereby the transmutability that makes our overall goal keep concentrating on to reduce shear stress, reduces turbulent and be reduced in needs poor to elevated pressures on the grafting vessel.
And, by in surgical operation, using artificial blood vessel of the present invention, because being located away from the blood flow branched portion anatomically, the damage that the grafting vessel stitching causes (sees Fig. 3 and 5.Cause like this separation of two kinds of different cell proliferation releasers: because the damage that the secondary inflammation causes, and the hematodinamics disturbance.
And the present invention has low energy consumption, keeps thus blood pressure in the bypass adjacent place.The present invention is in the on the whole optimization blood flow condition of grafting vessel, and not only in the anastomosis of receptor tremulous pulse, sees Fig. 6.The invention provides a kind of design, wherein, at the fork position, two outflow sections have different cross-sectional, and the outflow branch road has limitary curvature.We realize above-mentioned feature by using the Mohs law.These principles have formed the new approval of artificial blood vessel of the present invention and the basis of peculiar design.
Computer simulation
Artificial blood vessel of the present invention has makes it compare the multiple performance that improves to some extent with existing artificial blood vessel.For these improvement of illustration, we use the Three-D limited element plan to carry out computer simulation, with in contrast research.Fig. 6 demonstrates the computer simulation result with the blood flow that flows through the standard that the flows through grafting vessel that artificial blood vessel of the present invention compares.Map-area A: the blood flow in the standard bypass graft blood vessel.Attention: the distributary division 10 of the opposition side of the grafting vessel outlet in tremulous pulse.Map-area B: the blood flow in the artificial blood vessel of the present invention.Attention: do not have the distributary division with low flow velocity zone.Attention: the flow circuits of smooth curved.
Fig. 7 demonstrates the computer simulation result by the shear stress level of the grafting vessel of standard and new artificial blood vessel.Color is darker, and then shear stress is lower.Use same pressure difference at two kinds of grafting vessels.Map-area A: the shear stress in the standard bypass graft blood vessel.Attention: the shear stress of the reduced levels of comparing with artificial blood vessel of the present invention.Attention: high variable shear stress.Attention: the artery diameter expansion of inserting 11 places, position at grafting vessel.Map-area B: the shear stress in the artificial blood vessel of the present invention.Attention: the shear stress of higher level.Attention: low variable shear stress.Attention: do not have local variations of diameter at connecting portion.
These simulations clearly show that artificial blood vessel of the present invention provides:
Higher shear stress (Fig. 7) in the outflow section;
Low variable shear stress (Fig. 7);
There is not utmost point mild method (Fig. 7) at the shunting position;
Do not exist receptor tremulous pulse radius to change (Fig. 7) at connecting portion;
The probability less (Fig. 6) of turbulent flow;
There is the sectional area difference that flows out between the pipeline at branched portion, thereby will provides priority for the downstream main line.The secondary outflow end of nearside is tapered to be fit to the general diameter of receptor tremulous pulse;
The shear stress of the higher level that exists under the pressure differential of same degree is equivalent to the higher grafting vessel of efficiency;
Use the design with mobile relevant with the diameter optimal angle at fork position.
Material
Artificial blood vessel of the present invention is not limited to any material, but is preferably made by biocompatible material.Described material should further make artificial blood vessel can take and keep the geometry of its expectation under physiological condition after implanting.Described material can be the fluoroplastics material, for example, and expanded PTFE (ePTFE), tetrafluoroethene-perfluoroalkyl vinyl ether copolymer, tetrafluoroethene-hexafluoro polypropylene copolymer, or tetrafluoroethylene-ethylene copolymer.Described material also can be polyester, for example, but reaches synthetic fibre (Dacron).Described material also can be rubber type of material, for example, and ethylene-propylene copolymer, polyurethane, nitrile rubber, chlorination polyisoprene, acrylic rubber, butyl rubber, and halogenated butyl rubber, with the rubber-like elastomer, for example, ethene-vinyl acetate class elastomer, the butadiene type elastomer, amino elastomer, esters elastomer, the polyurethanes elastomer, alpha-olefines elastomer, and phenylethylene elastomer.
Described material preferably should self have the antithrombotic formative.If described material does not have or has hardly the antithrombotic formative, then can form the coating that material consists of by antithrombotic the inner surface setting of artificial blood vessel, perhaps, artificial blood vessel self can carry antithrombotic and form material.Antithrombotic forms material and is not limited to any concrete material, but can be the material based on heparin, collagen, colloid, urokinase, fibrin, aspirin or prostacyclin.
The material of artificial blood vessel of the present invention also can be made by the textured material that is made of monofilament lines fiber or composite fibre.Composite fibre is the fiber of making in the following manner: makes two or more polymer of different nature with the amount discharging of independent control, in one or same fusulus, mutually combines, and simultaneously rotation.Composite fibre can be made of polyethylene terephthalate and polyester elastomer, wherein is included in the polyester fiber that presents excellent stability in the live body in the polyethylene terephthalate.Described polyester for example comprises: polybutylene terephthalate, polyester-polyether block copolymer, and polyester-polyester copolymer.The polyester-polyester copolymer elastomer comprises aliphatic polyester, for example, and polyethylene terephthalate, polyethylene terephthalate-polyethylene terephthalate, or poly terephthalic acid-Isosorbide-5-Nitrae-hexamethylene dimethyl ester.
At least a structure the during artificial blood vessel of the present invention can be processed by aforementioned fibers is for example weaved (weaving), woollen yarn knitting (knitting), expansion (expansion) and braiding (braiding).
Artificial blood vessel of the present invention can be by combining weaving, woollen yarn knitting or woven fibre material to construct with molded or casting plastics, rubber or polymeric material.
Artificial blood vessel of the present invention can be enhanced and be beneficial to make it to keep geometry.Reinforce can be integrated in or bond to the wall of artificial blood vessel, for example comprises screw winding.
List of references:
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Fillinger?MF,Reinitz?ER,Schwartz?RA,Resetarits?DE,PaskanikAM,Bredenberg?CE.Beneficial?effects?of?banding?on?venousintimal-medial?hyperplasia?in?arteriovenous?loop?grafts.Am.J.Surg.1989;158(2):87-94
Geary?RL,Kohler?TR,Vergel?5,Kirkman?TR?and?Clowes?AW.Timecourse?of?flow?induced?smooth?muscle?cell?proliferation?and?intimalthickening?in?endothelial?ized?baboon?vascular?grafts.Circ.Res.1994;74:14-23.
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Morinaga?K,Eguchi?H,Miyazaki?T,Okadome?K?and?Sugimachi?K.Development?and?regression?of?intimal?thickening?of?arteriallytransplanted?autologous?vein?grafts?in?dogs.J.Vasc.Surg.1987;5:719-30.
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Claims (14)
1. bypass artificial blood vessel that comprises the fork-shaped pipeline that is used for the treatment of the obstructive angiopathy has:
Has the flow ipe that flows into end;
Distally main flow out branch with distally master's outflow end; With
Nearside secondary flow out branch with the secondary outflow end of nearside;
Described two outflow ends guide along different directions; And described two outflow branch roads have different cross-sectional in the adjacent place of branched portion;
Wherein, described nearside secondary flow out branch is more crooked than described distally main flow out branch, and the outflow angle (β) that enters described nearside secondary flow out branch from described flow ipe at branched portion is measured as in the scope of 30 to 90 degree between flow ipe middle part axis and nearside secondary flow out branch middle part axis, described nearside secondary flow out branch has less sectional area in the adjacent place of described branched portion than described distally main flow out branch, and has the cumulative sectional area from described branched portion to described outflow end.
2. artificial blood vessel according to claim 1, wherein, in the adjacent place of described branched portion, the ratio of the radius (r) of described nearside secondary flow out branch and the radius (ρ) of described flow ipe is in 0.4 to 0.69 scope.
3. artificial blood vessel according to claim 2, wherein, in the adjacent place of described branched portion, the ratio of the radius (r) of described nearside secondary flow out branch and the radius (ρ) of described flow ipe is in 0.45 to 0.65 scope.
4. artificial blood vessel according to claim 1, wherein, in the adjacent place of described branched portion, the ratio of the radius (R) of described distally main flow out branch and the radius (ρ) of described flow ipe is in 0.7 to 1.0 scope.
5. artificial blood vessel according to claim 4, wherein, in the adjacent place of described branched portion, the ratio of the radius (R) of described distally main flow out branch and the radius (ρ) of described flow ipe is in 0.75 to 0.95 scope.
6. artificial blood vessel according to claim 1 wherein, enters the outflow angle (α) of described distally main flow out branch in the scope of 0 to 40 degree from described flow ipe.
7. artificial blood vessel according to claim 6 wherein, enters the outflow angle (α) of described distally main flow out branch in the scope of 5 to 30 degree from described flow ipe.
8. artificial blood vessel according to claim 7 wherein, enters the outflow angle (α) of described distally main flow out branch in the scope of 8 to 25 degree from described flow ipe.
9. artificial blood vessel according to claim 1 wherein, enters the outflow angle (β) of described nearside secondary flow out branch in the scope of 40 to 70 degree from described flow ipe.
10. artificial blood vessel according to claim 9 wherein, enters the outflow angle (β) of described nearside secondary flow out branch in the scope of 45 to 65 degree from described flow ipe.
11. artificial blood vessel according to claim 1, wherein, all greater than the twice of the radius (ρ) of described flow ipe, the curved radius of curvature (rc) in the middle part of described nearside secondary flow out branch has the minima place less than six times of the radius (ρ) of described flow ipe at it to the curved radius of curvature (rc) in the middle part of described nearside secondary flow out branch at all sites.
12. each described artificial blood vessel according to claim 1-11, wherein, two outflow ends all are suitable for being connected to the tremulous pulse of radius in 0.5 to 10mm scope.
13. each described artificial blood vessel according to claim 1-11, wherein, one or two in the described outflow end is that taper is to be fit to the receptor tremulous pulse.
14. each described artificial blood vessel according to claim 1-11 wherein, enters the outflow angle (β) of the secondary outflow end of described nearside greater than the outflow angle (α) that enters described distally master's outflow end from described flow ipe from described flow ipe.
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SE0701152A SE531374C2 (en) | 2007-05-14 | 2007-05-14 | New vascular prosthesis |
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US93925007P | 2007-05-21 | 2007-05-21 | |
US60/939,250 | 2007-05-21 | ||
PCT/EP2008/055929 WO2008138956A1 (en) | 2007-05-14 | 2008-05-14 | New vascular prostheses |
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CN101711138B true CN101711138B (en) | 2013-03-13 |
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JP (1) | JP5253499B2 (en) |
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WO2007089500A2 (en) | 2006-01-30 | 2007-08-09 | Pong-Jeu Lu | Dual-pulsation bi-ventricular assist device |
US8523756B2 (en) | 2008-12-31 | 2013-09-03 | National Cheng Kung University | Cardiac compression system |
US8833402B2 (en) * | 2010-12-30 | 2014-09-16 | Cook Medical Technologies Llc | Woven fabric having composite yarns for endoluminal devices |
EP2739327B1 (en) | 2011-08-01 | 2019-07-24 | Laminate Medical Technologies Ltd | Vessel shaping devices |
CN104837514B (en) | 2012-08-01 | 2017-05-17 | 拉米内特医疗技术有限公司 | Apparatus for configuring an arteriovenous fistula |
US9814563B1 (en) * | 2014-04-25 | 2017-11-14 | David M. Hoganson | Hemodynamically optimized shunt |
DE102014222804B4 (en) | 2014-11-07 | 2023-12-28 | Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. | Device and method for determining a wall shear stress and system for detecting arteriosclerosis |
CN104758980B (en) * | 2015-02-03 | 2018-02-09 | 北京航空航天大学 | A kind of method that external structure has the intravascular cortex of anti-Osima jacoti, Osima excavata and anti-platelet aggregation function |
US11518069B2 (en) | 2018-05-21 | 2022-12-06 | The University Of Sydney | Method of fabricating a casting |
US11369381B2 (en) * | 2019-07-02 | 2022-06-28 | Washington University | Tailored venous anastomosis for arteriovenous grafts |
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2008
- 2008-05-14 US US12/153,087 patent/US9636208B2/en not_active Expired - Fee Related
- 2008-05-14 WO PCT/EP2008/055929 patent/WO2008138956A1/en active Application Filing
- 2008-05-14 CN CN2008800160056A patent/CN101711138B/en not_active Expired - Fee Related
- 2008-05-14 EP EP08759606A patent/EP2152199B1/en not_active Not-in-force
- 2008-05-14 AU AU2008250001A patent/AU2008250001A1/en not_active Abandoned
- 2008-05-14 AT AT08759606T patent/ATE542493T1/en active
- 2008-05-14 JP JP2010507916A patent/JP5253499B2/en not_active Expired - Fee Related
- 2008-05-14 CA CA002685050A patent/CA2685050A1/en not_active Abandoned
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ATE542493T1 (en) | 2012-02-15 |
CA2685050A1 (en) | 2008-11-20 |
JP5253499B2 (en) | 2013-07-31 |
SE531374C2 (en) | 2009-03-17 |
CN101711138A (en) | 2010-05-19 |
SE0701152L (en) | 2008-11-15 |
US20080294245A1 (en) | 2008-11-27 |
JP2010527646A (en) | 2010-08-19 |
EP2152199B1 (en) | 2012-01-25 |
EP2152199A1 (en) | 2010-02-17 |
WO2008138956A1 (en) | 2008-11-20 |
AU2008250001A1 (en) | 2008-11-20 |
US9636208B2 (en) | 2017-05-02 |
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